BASICS OF NTEP

NTEP Organogram
•STO, Deputy STO, MO
•APO/Epidemiologist
•TB-HIV Coordinator
Central TB Division/DGHS •IEC Officer
•Accountant STDC
•Pharmacist / Store Keeper •Microbiologist for IRL
•Sec Assistant •EQA Microbiologist for IRL
State TB Cell •DEO
•PPM coordinator
•Senior LT for IRL

•DRTB Coordinator

DRTB SIte
District •DTO, MO-DTC, • MO
Hosp District TB •TB-HIV+DOTS-Plus Sup
• DPC
• SA

Centre •Data Entry Operator Medical college

•PPM coordinator • MO
• LT
• TBHV

Block Tuberculosis •MO-TC

•STS
BPHC Unit •STLS
1 / 250,000

PHC/BPHC/ Microscopy Centre •MO

RH/SDH / 1 /100,000 •LT
DH

All PHIs/SC/ •Treatment supporter

Treatment •TB-HV (Urban areas)
ASHA/AW
Center
 Commissioner

Health
Department

Dy Municipal Commissioner of Health

Medical officer Health

District TB
Centre

TB Unit TB Unit TB Unit TB Unit

Designated Designated Designated Designated

Microscopy Microscopy Microsopy Microscopy
Centre (DMC) Centre (DMC) Centre (DMC) Centre (DMC)

Peripheral
Peripheral Health Peripheral Health
Health Institute
Institute (PHI) Institute (PHI)
(PHI)

DOT Centre
 Global (Million) India
Incidence TB
cases 10 2.6 Million

Mortality of
TB 1.2 436,000
Incidence
HIV-TB 0.82 71,000
Mortality of
HIV-TB 0.21 9,500
Estimated
MDR/RR 0.47 124,000
cases
ESTIMATED PROPORTION OF TB CASES
WITH MDR/RR-TB, 2019

New cases 2.8% (2.3–3.5)

Previously treated 14% (14–14)
cases
 India’s Commitment to End TB

• The Sustainable Development Goals (SDGs) for 2030 were adopted by the
United NationsVision:
in 2015
Reduction in number of TB
India free TARGETS
of TB (Zero deaths, Zero TB, Zero
deaths
Compared with 2015sufferings) TARGETS
Reduction in TB incidence INDIA
INDIA SDG
SDG End
End
rate TB
TB
Compared with 2015 (217 cases per 1
lakh)
2025 203 203
Reduce catastrophic costs
due to TB
2025 203
0 203
5
Reduction in number of TB 90%
0 5
90% 95%
deaths
Compared with 2015 (%) 90% 90% 95%
(3 per lakh)
Reduction in TB incidence 80% 80% 90%
 Definitions of Presumptive
TB
Presumptive Pulmonary TB refers to a person with any of the symptoms
and signs suggestive of TB including cough for > 2 weeks, fever>2 weeks,
significant weight loss, haemoptysis, any abnormality in chest radiograph.

Note: In addition , contacts of microbiologically confirmed TB patients,

PLHIV , Diabetics, Malnourished, cancer patients, patients on immuno-
suppressants or steroids should be regularly screened for sign and
symptoms of TB

Presumptive Extra Pulmonary TB refers to the presence of organ specific

symptoms and signs like swelling of lymph node, pain and swelling in
joints, neck stiffness, disorientation , etc., and/or constitutional symptoms
like significant weight loss, persistent fever for ≥ 2 weeks , night sweats.
 Definitions of Presumptive TB

Presumptive Paediatric TB refers to children with persistent fever

and / or cough for more than 2 weeks loss of weight*/no weight
gain and/or history of contact with infectious TB case**.
* History of unexplained weight loss or no weight gain in past 3
months ; loss of weight is defined as loss of more than 5% body
weight as compared to highest weight recorded in last 3
months.**In a symptomatic child contact with a person with any
form of active TB within last 2 years may be significant.

Presumptive DR-TB refers to those Tb patients who have failed

treatment with first line drugs, Paediatric TB non responders, TB
patients who are contact of DR-TB (or Rif resistance), TB patient
who are found positive on any follow - up smear examination during
 Diagnostic Tools

Sputum
Smear Culture: Rapid
Microscopy Solid(Lowenstein Molecular
(for AFB):
Jensen) media diagnostic
& testing:
Zeihl -Neelson
Staining Automated Line Probe
Liquid Culture Assay (LPA)
& System eg.
Fluorescent BACTEC MGIT & CBNAAT
Staining
Tools for microbiological
confirmation of TB
 Treatment Initiation- Algorithm

CBNAAT Result
MTB and Rif MTB Detected
MTB detected MTB not
and Rif Ind / Error/ no result Invalid
Res detected and Rif Sen detected
invalid
Repeat test on
H/o Previous No H/o Previous H/o of previous No H/o Previous Resend fresh Rule out other Repeat test in
same sample if
Treatment treatment treatment treatment sample Diff Diag second sample
available

Initiate Regimen
Refer to DR TB Confirmatory Initiate Regimen Rif
for new TB
Centre Repeat CBNAAT for PT TB patient Indeterminate
patient

Send fresh
Rif Res Rif Sen sample for
C&DST

Refer to DR TB Test with

Centre LPA/liquid

Decide treatment
as per result of DST

12
 Critical Issues in TB diagnosis
• Smear Microscopy is not very sensitive to detect all
smear+ve cases
• Need for improving sens of the technique by various
means
• Use of rapid technology (POC) for improving sens for
early and complete case detection including smear
negative cases, EPTB, Paediatric .
• Rapid ID for +ve cultures
• Rapid methods for detection of DRTB especially
MDR/XDR

UNITE TO END TB
Which are the techniques and equipent to
diagnose TB & DRTB?
• LED based Microscopy
• Liquid Culture Systems (automated & Manual)
• Rapid Identification of species by capilia(ICT)
test.
• Molecular Methods
– Line Probe Assays
– Automated NAAT (GeneXpert)
– TRUENAT ( 2020 )
– Genome Sequencing ( 2020 )
UNITE TO END TB 14
 Smear Microscopy

• The technique – ZN Microscopy

– Sputum volume and quality
– Collect multiple specimens
– Detection limit for good microscopy
services– 5000-10000 b/ml (65-95%) chance
of +ve
– Poor microscopy – (35%) 30000-60000b/ml
– smears/day ( not to exceed 20-25/day for
TB work
UNITE TO END TB
 Optimizing Smear Microscopy
• Use of LED based Systems – for smear microscopy
• Advantages:
– LED based light source which is cheap and maintenance
free
– Dual Mode – both bright field and Fluorescent option
– No radiation hazard (UV)
– Long bulb life > 50,000 hrs
– Battery operated option available (no need for continuous
power supply)
– Fluoresent microscopy – can be used under lower
magnification (hence less time)
– WHO approved – November 2009
UNITE TO END TB
• IMPROVE AND INCREASE CASE
DETECTION BY SOLID /LIQUID
CULTURE METHOD AND NAAT
METHOD.

UNITE TO END TB
 Culture contd
• Liquid more sensitive than solid
• Solid alone 70-80 to liquid alone 82-84%
• Best is the combination of solid+liquid which improves
sensitivity to 87-89%
• Newer advances are a combination of re-invention
older methods and newer rapid methods
• Use only for Follow Up of DRTB Rx & Smear positive
but M.tb Not detected by LPA/CBNAAT ( ??? Presence
of NTM in Biological specimen)……..

UNITE TO END TB
 Solid Culture & DST
• Conventional LJ, Agar etc
• 2-8 weeks for detection
• 8-12 weeks for DST
• Time tested, robust,
presumptive ID
• Biosafety
• Most newer methods of
DST compared to this as
“gold standard”
MGIT +ve tubes MGIT 960 instrument

UNITE TO END TB 20
 Molecular Methods

– Line Probe Assays ( R,H,FLQ,SLID)

– Automated NAAT (GeneXpert)(Only Rif …Cartridge will be

updated for R,H,FLQ,SLID ….. Study is ongoing )

– TRUENAT (Golbal study for Evaluation ) (For TB & Rif.)

– (Whole genome sequencing (WGS) – The process of determining the

complete genome sequence for a given organism at one time through NGS. This method can determine the order
of all nucleotides in a given genome and detect any variations relative to a reference genome using bioinformatics

analyses. Will Use in special Situation )

UNITE TO END TB
Integrated automated NAAT: Cepheid Concentrates bacilli &
removes inhibitors

Sample is Ultrasonic lysis of filter-

End of hands on work automatically captured organisms to
4
filtered & washed release DNA
3
5

DNA molecules are mix

with dry PCR reagen

Semi-nested real-t
amplification & detect
Transfer of 2 ml GeneXpert in integrated reaction tu
after 15 min

Time-to-result: 1 h 45 min
2 7

1
Sputum liquefaction & 22
inactivation with 2:1 SR UNITE TO END TB
Printable test result
 TRUENAT

Truenat MTB & Truenat MTB RIF: Ready to use

smart chips: TB case detection and Rif
resistance detection

UNITE TO END TB
 Importance of early diagnosis:
Sensitivity (cfu/ml) of PTB tests in portfolio
Capilia*
iLED* speciation
Target sensitivity range of FIND antigen fluorescent dipstick (of
detection tests microscope culture)
10,000/ml 1,000,000/ml

Line-probe*
10,000/ml
LAMP-TB
50-150/ml

Xpert MTB*
50-150/ml
MGIT*
10-100/ml

0 1 2 3 4 5 6
Log cful/ml
*development
24 completed UNITE TO END TB
 Methods for drug susceptibility testing

Rapid molecular Drug Resistance Testing Growth-based

(DRT) - Genotype phenotypic drug
susceptibility
testing (DST) first-
Nucleic Acid line drugs: R, H, E,
Line Probe Assay
Amplification Test Z second-line
(LPA)
(NAAT) drugs: S, Lfx, Mfx,
Km, Cm, Am
other drugs: Lzd,
cartridge Second line
based
chip based
First line (H (Lfx, Mfx, Cfz, Bdq*, Dlm*
TruNAAT PAS etc.,
Gene-Xpert & R) Km, Cm,
platform
platform Am)

Genotypic testing is much faster

UNITE TOthan
END TB phenotypic methods.
 Choice of diagnostic technology
DR diagnostic technology Choice
NAAT/LPA First
Liquid culture isolation and LPA DST Second
Liquid culture isolation and liquid DST Third

Turnaround time

Solid LJ media- of up to 84 days,

Liquid Culture (MGIT) up to 42 days,
LPA up to 72 hours
NAAT - 2 hours.
UNITE TO END TB
Airborne Infection Control at High risk
facilities
Role of the Health staff in TB infection control

 Fast Tracking of chest symptomatic

• ART centres should be located not
adjacent to DMC / DOT centres
 Ensure that any TB suspect should be
attended by the MO on priority and
should also be prioritized for testing and
lab investigations

 Instigating practices of good cough

hygiene for all patients, with any
symptom of cough at all for airborne
infection control